NCT04101747

To Explore the Diversity of Intestinal Flora in Patients With Advanced HCC Combin ed With Anti-PD-1 and Targeted Drug Therapy and the Correlation Between Metabolites and Therapeutic Effect

To Explore the Diversity of Intestinal Flora in Patients With Advanced Hepatocellular Carcinoma Receiving Anti-PD-1 Combined With Targeted Drug Therapy and the Correlation Between Metabolites and Therapeutic Effect:A Multi-Center Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is to explore the correlation between intestinal flora diversity and meta bolites in patients with advanced lver cancer rceiving Anti-PD-1 combined target-ed drug therapy,so that to get the analysis of intestinal flora of PD-1 inhibitors in liver cancer.

Detailed description

The combination of PD-1/PD-L1 inhibitors and targeted drugs as a promising strategy for the treatment of hepatocellular carcinoma has a breakthrough significance for the treatment of some advanced and refractory tumors.However,studies have shown that intestinal flora diversity indicates a good prognosis of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer, the intestinal flora analysis of PD-1 inhibitors in hepatocellular carcinoma is still a new field to be explored. This study is to select patients who meet the criteria of entry and discharge, sign informed consent, obtain patients'clinical data, pathological and case data, and enter the database. Before the treatment of PD-1 (no more than 24 hours), during the treatment of PD-1 (every time before treatment, three weeks, a total of 11 follow-up visits), at the end of treatment, fecal samples were collected in sterile containers for 5-10g, and feces were stored at 4 degrees C, frozen at - 80 degrees C within 24 hours; the response to treatment was evaluated every 6 weeks, and the disease was first evaluated clinically. The patients were divided into response group (R) (partial response or stable condition) or non-response group (NR) (disease progression) according to RECIST 1.1 evaluation criteria. Subgroup had high diversity of bacteria and low diversity of bacteria, and were observed continuously until the end of treatment. The bacterial ribosomal DNA was extracted, metabolites were detected and flow cytometry was used to analyze the data. The baseline intestinal microflora diversity, microflora diversity mapping, continuous Shannon index curve change mapping were compared between groups and within groups, and correlation validation was carried out.

Conditions

• Advanced Hepatocellular Carcinoma

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2019-09-24
• Last updated: 2019-09-24